EXTRACT: "...this new proposal uses a secret approval process wherein no one other than FDA reviewers can see the data submitted before final approval. And, unlike drugs which can be recalled because they are labeled, FDA maintains that genetically engineered animals should not be labeled.

"...Secret approval and lack of labeling indicates a complete lack of transparency and the potential conflicts of interest in an industry as small as the cloning/GE animal business cannot be reviewed without an open process."
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Center for Food Safety responds to FDA rules on genetically engineered animals
Source: Center for Food Safety
Press release, September 18 2008
http://wistechnology.com/articles/5041/

Washington, D.C. - The Center for Food Safety issued a statement in response to the Food and Drug Administration's (FDA) release of a draft guidance outlining the approval process for genetically engineered (GE) animals. Jaydee Hanson, Policy Analyst on cloning and genetics for the Center for Food Safety, reacted to the FDA draft of the GE animal approval process, issued by the agency today:

"The FDA draft guidance released this morning would treat genetically engineered animals under its new animal drug provisions. While the new guidance would require a long-overdue mandatory review process, the proposed FDA rules are seriously flawed.

"At a time when the FDA has inadequate resources to protect the food system and is reeling under allegations of conflicts of interest, this new proposal uses a secret approval process wherein no one other than FDA reviewers can see the data submitted before final approval. And, unlike drugs which can be recalled because they are labeled, FDA maintains that genetically engineered animals should not be labeled.

“Under this draft, the public cannot know if the review of a product met the highest scientific standards until after its approval, and then they cannot avoid the product in the marketplace because it is not labeled. The FDA feels it deserves the public's trust, but refuses to give us the tools to verify that it is doing its job fairly and adequately.

“While we support many features of the new animal drug process; it has major deficiencies for reviewing a technology as new as GE animals. Secret approval and lack of labeling indicates a complete lack of transparency and the potential conflicts of interest in an industry as small as the cloning/GE animal business cannot be reviewed without an open process. The FDA needs to request Congress to amend the new animal drug law so that the process is transparent AND it needs to require labeling so that the public can report any problems they discover with the product.”

In 2001, the Center petitioned the FDA to regulate GE salmon as a new animal drug (the application is still pending) and also petitioned four other agencies to regulate environmental aspects of GE salmon. In 2002, the National Academy of Sciences issued a report saying that GE fish could cause significant environmental problems. CFS has worked with many states to pass laws and regulations on GE fish: California, Washington, Oregon, Maryland, Michigan, Florida and Alaska have all passed laws or rules regulating GE salmon, and Alaska requires labeling for any GE fish product.

Additionally, the Center for Food Safety has consistently advocated in its comments on animal cloning and in a legal petition to the FDA that animal cloning should also be covered by the new animal drug rubric.

About the Center for Food Safety

The Center for Food Safety is national, non-profit, membership organization founded in 1997 to protect human health and the environment by curbing the use of harmful food production technologies and by promoting organic and other forms of sustainable agriculture.